United Kingdom Patent Application No. 0116605.7 filed in Jul. 7, 2001 is incorporated herein by reference.
The present invention relates to an anchoring device and, in particular, but not exclusively, to an anchoring device for urging a ligament transplant against the wall of a bone hole during ligament replacement and for fixing the anchor in position in the said bone hole.
Due to increasing involvement of people with active sport, injuries are becoming increasingly common where tissues such as ligaments or tendons tear or detach from bone. Surgical techniques have been developed to reconstruct such torn soft tissues and to re-attach them to the relevant bone. One of the most common types of such injuries is tearing of the Anterior Cruciate Ligament (ACL). The Anterior Cruciate Ligament connects the femur to the tibia at the centre of the knee joint. Reconstruction of such tissues generally involves replacement with a graft such as autologous or artificial tendon. An autologous tendon graft may be taken from the patients patellar tendon or, alternatively, the semitendinosus may be utilised. A typical fixation technique involves the use of a circular button fixation device which is located on the outside of the femur above the knee. As this is some distance from the site where the graft will be utilised in the knee joint, sutures are used to attach the graft to a femur button. The main disadvantage of this technique is that incisions need to be made through the skin and quadriceps muscle resulting in trauma to the leg and a cosmetically undesirable procedure.
Use of the femur button also involves laborious measurement of lengths and drilling with two drill diameters.
U.S. Pat. No. 5,645,588 describes an improved technique whereby the ligament anchor may be threaded through a femoral tunnel formed through the femur from the centre of the knee.
PCT/US97/22061 provides an interference fit insertion element with a proximal aperture through which a graft may be threaded or attached. The technique involves securement of the interference end of the device into the central cancellous area of the bone.
U.S. Pat. No. 5,037,422 also relates to the anchoring of sutures for securement of a suture to a bore hole in a bone. The device is shown secured to the cancellous bone. The device is for use in soft tissue fixation to the outside of the bone and not fixation within the bone hole itself.
A device for graft fixation using sutures is described in EP 0 619 982 where the anchor includes a body and a plurality of barbs located in axially aligned, circumferentially spaced relation to each other about the body. The barbs have a normal configuration wherein they extend rearwardly and radially outwardly from the anchor body to outer ends which are normally located outside a longitudinal projection of the largest geometric cross-section of the body transverse to its longitudinal axis. The device relies upon interference between the barbs and the soft cancellous bone area. This interference fit is not only difficult to insert for reasons of space but also involves some risk of damage to the transplant.
Interference fit bone anchors are, therefore, increasingly common for ligament fixation. A problem for the surgeon fitting the device is how to insert the device without the interfering projections impeding the initial location in the closely fitting bone hole. EP 1066805 solves this problem by using a cruciform device which expands at the distal end when the replacement ligament is tensioned ie. after the cruciform anchor has been located in position.
Nevertheless, there is still a general problem in the prior art in how to easily insert an anchor which is designed to be a very tight fit in a bone hole.
According to a first aspect of the present invention there is provided an anchoring device for urging a ligament against a bone surface within a tunnel formed in a bone of a patient comprising a first component and a second component, the first and second component being designed for mutual sliding co-operation between a first anchor inserting position and a second fixation position, said sliding co-operation being provided along respective parallel inner mating surfaces of each component which surfaces are each in angular relation to the respective component outer surfaces and in opposed angular relation to each other so that in the anchor insertion position the width of the said anchoring device is in an elongate narrow mode with respect to a bone hole and, in the fixation position, the width of the said anchoring device is in a compressed wide mode to thereby urge the ligament against the wall of the bone hole.
Preferably, the first and second component include mutual engaging means on their respective inner surfaces for multiple position fixation.
Preferably, the first or second component has an elongate tongue and the second or first component respectively has an accommodating elongate groove wherein the tongue slides in the groove between the said anchor inserting and fixating positions.
The first and second component each have a leading end which is inserted into the bone hole first and a trailing end which is opposite the leading end.
Preferably, the anchor device includes a terminal abutment at the trailing end ie. remote from the inner end of the bone hole to thereby provide a limit of extension of the anchor.
Preferably, the anchor also includes a terminal abutment at the leading end ie. the end adjacent to the inner end of the bone hole, in use, to provide a limit of longitudinal compression of the trailing component of the anchor. Preferably, the leading ends of the first and second components and the location of the leading end terminal abutment are such that the respective leading ends are substantially contiguous at the limit of compression to prevent damage to ligament located thereover. Advantageously, the terminal abutment improves the lateral interlocking of the anchor device, preferably provided by a tongue and groove arrangement, by extending it to terminal interlocking at the limits of elongation and compression.
Preferably, the trailing ends are also substantially contiguous at the limit of said compression. Preferably, therefore, the respective leading ends and respective trailing ends are axially displaced from each other in the elongate inserting position of the anchor device.
Further grooves may be provided on the outer surface of the first and/or second component to conveniently locate and guide a ligament transplant thereon. The grooves are positioned so that the transplant may loop over the leading ends of the anchor device or they may be designed to accommodate the transplant on one side of the device.
Preferably, an elongate positioning bore is provided in the anchor device. Preferably, the said bore extends in two sections through both the first and second component in such a manner that the bore sections are aligned in the said first elongate position. Advantageously, a positioning tool can be inserted through both bore sections in the said first position to thereby lock the two mating inner surfaces and hence the two components together during insertion in the bone hole.
An insertion takes place with the components in the elongate position, the leading component is located in the fixation position whilst the other component remains in the trailing position.
After insertion is complete, the positioning member is removed so that the trailing component may be pushed into the fixation position. Pushing the trailing component into position progressively widens the anchor device to thereby urge the transplant against the walls of the bone hole and secure the anchor in position.
The mutual engaging means provide incremental means to increasingly widen the anchor in the bone hole until a secure width is obtained, preferably, the secure width is that width wherein the leading ends of the first and second component become contiguous.
In one embodiment, the first component is shaped in the form of a blade, the outer edge of the said blade (ie. the edge adjacent the walls of the bone hole in use) projecting out from the second component and the inner edge, preferably, providing the tongue for sliding in the groove of the second component. In this manner, the portion of the sides of the blade which project from the surface of the second component and a portion of the surface of the second component adjacent to the said projecting surface may provide an elongate recess for location of the transplant on either side thereof.
The leading and/or trailing ends of the blade may be suitably stepped with respect to the respective leading and trailing ends of the tongue section to co-operate with respective terminal abutments in the groove and still provide contiguity with the second component in the fixation position.
In any embodiment, the mutual engaging means may be provided between mating surfaces, preferably along inner surfaces adjacent to the tongue and/or groove and extending outwards substantially perpendicular thereto.
According to a second aspect of the present invention there is provided a method of ligament fixation in a bone hole comprising the steps of:
forming a tunnel in a bone;
inserting a ligament transplant and an anchor device according to the first aspect of the invention in the bone hole whilst in the anchor insertion or elongate position of the said device; and
urging the trailing component into the fixating position to thereby urge the transplant against the bone hole and to fix the anchor in the said bone hole.
Preferably, the method includes the steps of:
inserting a positioning tool into the anchor device in the said first position prior to locating the anchor device in the bone hole and utilising the positioning tool to locate the anchor device in the bone hole.
Preferably, the positioning tool is removed prior to urging the anchor device into the fixating position.
The outer surfaces of the anchor device may include projections to aid fixation in the bone hole. Various types of projections are present in the art and will be known to those skilled in the art.
The inner or leading end of the anchor device may be planar or semispherical or any other of the suitable shapes which are known to those skilled in the art.
Although the anchor device is expected to be used in ligament fixation, it can be used in other fixation operations where securement of an anchor device in a bone hole is necessary, for instance, bone plate fixation onto the surface of a bone.